NCT04607330

Protein Top-up Acceptability Study for Patients With Increased Protein Needs

Acceptability of a Ready to Use, Low Calorie, Low Volume, High Protein Liquid for Patients With Increased Protein Needs

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Nutricia UK Ltd · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

The aim of this prospective, single-arm intervention study is to evaluate the acceptability (compliance, gastrointestinal tolerance, and palatability) to a low calorie, low volume, ready to use, high protein liquid in patients with elevated protein needs.

Detailed description

Increased protein needs are frequently observed in disease and can be difficult for patients to achieve where oral food intake is compromised.Where a standard ONS or enteral tube feed cannot meet the needs of patients, a modular feed can be added to the regimen, a low calorie, low volume, ready to use, high protein liquid may help meet protein needs while preventing caloric overfeeding. 40 patients will be recruited in an attempt to evaluate the acceptability (compliance, gastrointestinal tolerance, and palatability) to a low calorie, low volume, ready to use, high protein liquid in patients with elevated protein needs. After a 1-day baseline period to establish patients' acceptability, gastrointestinal tolerance, compliance and dietary intake with their currently prescribed nutritional regimen, each patient will receive the high protein liquid feed daily for 28 days.

Conditions

• Cancer
• Neurological Injury
• Respiratory Disease
• Stroke

Interventions

Type	Name	Description
OTHER	High protein liquid	After a 1-day baseline period to establish patients' acceptability, gastrointestinal tolerance, compliance, dietary intake while also capturing information related to user experience, risk of malnutrition, physical function, dietary intake, anthropometry and safety with their currently prescribed nutritional regimen, each patient will receive the high protein liquid daily for 28 days where the same measures will be replicated. The amount of the high protein liquid prescribed will always be completed by the patients' managing dietitian.

Timeline

• Start date: 2020-10-28
• Primary completion: 2022-05-30
• Completion: 2022-06-28
• First posted: 2020-10-29
• Last updated: 2023-04-20

Locations

2 sites across 1 country: United Kingdom